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Lilly asks to revoke emergency authorisation for bamlanivimab monotherapy in the US

Decision prompted by the ‘evolving variant landscape’ in the US

Eli Lilly has asked the US Food and Drug Administration (FDA) to revoke the emergency use authorisation (EUA) for its COVID-19 drug bamlanivimab when administered alone.

In November, the FDA granted the neutralising monoclonal antibody (mAb) an EUA for the treatment of mild-to-moderate COVID-19.

Following this, Lilly advanced the further development of bamlanivimab plus another of its neutralising mAbs – etesevimab – to be administered together.

The reason for this, according to Lilly, was to address the potential challenge of treatment resistant variants, which were likely to resist treatment with either mAb when used alone.

“Due to the rapidly evolving and geographically diverse nature of the SARS-CoV-2 virus, continued scientific innovation remains critical to develop additional treatments,” said Lilly.

The company added that it is ‘committed’ to developing further treatment to address potential future SARS-CoV-2 variants.

In March, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued advice recommending the use of bamlanivimab plus etesevimab to treat confirmed COVID-19 in high-risk patients who do not require supplemental oxygen.

In the phase 3 BLAZE-1 trial, the combination of bamlanivimab and etesevimab significantly reduced the risk of hospitalisations and death in high-risk COVID-19 patients.

Across the study population, which included 1,035 patients, there were 11 events in patients receiving Lilly’s antibody combination treatment, while 36 events occurred in the placebo group.

This represented a 70% risk reduction, with no deaths occurring in the bamlanivimab and etesevimab-treated group.

The antibody combination treatment also demonstrated significant improvements in all key secondary endpoints, with strong evidence that the therapy reduced viral load and accelerated symptom resolution, according to Lilly.

The CHMP also recommended that bamlanivimab can be used as a monotherapy for the treatment of the same patients.

However, Lilly said that it is not requesting the withdrawal of emergency authorisation for bamlanivimab alone in any other jurisdiction ‘at this time’.

Article by
Lucy Parsons

16th April 2021

From: Regulatory



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